Cleared Traditional

K042051 - ARCOMXL POLYETHYLENE LINERS

K042051 is an FDA 510(k) clearance for ARCOMXL POLYETHYLENE LINERS, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K042051 · Biomet, Inc. · Orthopedic device
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Mar 2005
Decision
221d
Days
Class 2
Risk

K042051 is an FDA 510(k) clearance for the ARCOMXL POLYETHYLENE LINERS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 8, 2005 after a review of 221 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomet, Inc. devices

FDA 510(k) Submission Details - K042051

510(k) Number K042051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2004
Decision Date March 08, 2005
Days to Decision 221 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 122d · This submission: 221d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPH Device Classification - Class 2, Special Controls

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 543
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K042051.
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K050937 · Zimmer Trabecular · May 2005
RX90 LOW PROFILE ACETABULAR SYSTEM
K042989 · Biomet, Inc. · Apr 2005
ENCOMPASS HIP STEM, TRI-PLUS ACETABULAR SHELL, TRI-PLUS DCM LINER
K042565 · Ortho Development Corp. · Apr 2005
TRIDENT ACETABULAR SYSTEM
K033716 · Howmedica Osteonics Corp. · Feb 2005
APEX MODULAR HA HIP STEM
K043123 · Apex Surgical, LLC · Feb 2005
MALLORY-HEAD MODULAR CALCAR STEMS WITH INTERLOCKING SLOTS
K042774 · Biomet, Inc. · Jan 2005